Method for the immunochemical determination of hepatitis B core antigens

Abstract

The present invention concerns a method for detection of the core antigen of hepatitis B virus in a sample comprising a first incubation with carrier-bound antibodies directed against hepatitis B surface antigens and a second incubation with antibodies against the core antigen in the presence of a detergent. Also claimed are test kits for carrying out this method and an immunochemical reagent comprising antibodies directed against the surface antigen and against the core antigen conjointly bound to a carrier.

We claim: 
     
       1. Method for the qualitative and/or quantitative immunochemical determination of hepatitis B core antigens (HBcAg), comprising incubating a liquid sample with carrier-bound immunoglobulins directed against hepatitis B surface antigens (HBsAg), separating the carrier-bound and liquid phases from one another, incubating the carrier-bound phase with an agent that breaks the HBsAg coat and releases HBcAg forming a solution with any HBcAg released, simultaneously with or subsequently to forming the solution incubating said solution with immunoglobulins directed against HBcAg, and determining the binding of HBcAg to immunoglobulins directed against HBcAg, giving a qualitative and/or quantitative measure of HBcAg in the sample. 
     
     
       2. Method according to claim 1, wherein the incubation with immunoglobulins directed against HBcAg is carried out with carrier-bound and labelling-agent-bound immunoglobulins, after which any binding of HBcAg to immunoglobulins is determined by measuring the carrier-bound or the free labelling agent. 
     
     
       3. Method according to claim 2, comprising employing a carrier to which the immunoglobulins directed against HBcAg and against HBsAg are conjointly bound. 
     
     
       4. Method according to claim 2 comprising employing an enzyme as the labelling agent. 
     
     
       5. Method according to claim 1, wherein the incubation with immunoglobulins directed against HBcAg is carried out with said immunoglobulins bound to particles. 
     
     
       6. Test kit for caryring out the determination according to claim 1, comprising carrier-bound immunoglobulins directed against HBsAg; immunoglobulins directed against HBcAg; and an agent effective for breaking down the HBsAg coat. 
     
     
       7. Test kit according to claim 6 further comprising which are bound immunoglobulins directd against HBsAg, labelling-agent-bound immunoglobulins directed against HBcAg. 
     
     
       8. Test kit according to claim 6 comprising immunoglobulins directed against HBsAg bound to a first carrier; immunoglobulins directed against HBcAg bound to a second carrier; and immunoglobulins directed against HBcAg, bound to a labelling agent. 
     
     
       9. Test kit according to claim 7 comprising an enzyme as labelling agent. 
     
     
       10. Test kit according to claim 9, comprising a substrate for the enzyme. 
     
     
       11. Test kit according to claim 6, comprising immunoglobulins directed against HBsAg, bound to a carrier; and immunoglobulins directed against HBcAg, bound to particles. 
     
     
       12. Test kit according to claim 6, wherein the agent effective for breaking down the HBsAg coat comprises a detergent. 
     
     
       13. Test kit according to claim 12, comprising a non-ionic detergent. 
     
     
       14. Immunochemical reagent comprising antibodies directed against HBsAg and against HBcAg conjointly bound to a carrier. 
     
     
       15. Method according to claim 3, comprising employing an enzyme as the labelling agent. 
     
     
       16. Test kit according to claim 8, comprising an enzyme as labelling agent. 
     
     
       17. Test kit according to claim 7, wherein the agent effective for breaking down the HBsAg coat comprises a detergent. 
     
     
       18. Test kit according to claim 8, wherein the agent effective for breaking down the HBsAg coat comprises a detergent. 
     
     
       19. Test kit according to claim 9, wherein the agent effective for breaking down the HBsAg coat comprises a detergent. 
     
     
       20. Test kit according to claim 10, wherein the agent effective for breaking down the HBsAg coat comprises a detergent. 
     
     
       21. Test kit according to claim 11, wherein the agent effective for breaking down the HBsAg coat comprises a detergent.